How different drugs affect BIS-EEG during anesthesia with propofol-remifentanil

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this single-center randomized trial, adults undergoing elective laparoscopic cholecystectomy with propofol-remifentanil anesthesia will be assigned to receive either midazolam, dexmedetomidine, esketamine, or no additional drug. Continuous BIS values and raw EEG signals will be recorded to see how each adjunct drug influences brain activity measurements beyond the expected depth of anesthesia. The goal is to determine whether BIS readings remain accurate when multiple anesthetic drugs are used. The study will help clarify whether BIS-EEG monitoring can reliably reflect anesthesia depth in this multi-drug context.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ASA physical status I-II;
2. BMI 18-28 kg/m²;
3. Scheduled for elective laparoscopic cholecystectomy, with an expected surgical duration from skin incision to completion of wound closure of ≥45 min;
4. Planned to receive propofol-remifentanil total intravenous anesthesia, with routine intraoperative BIS monitoring and simultaneous acquisition of raw EEG signals;
5. Voluntarily agrees to participate in this study, has signed the informed consent form, and is able to cooperate with the intervention and assessment procedures.

Exclusion Criteria:

1. A confirmed history of psychiatric or neurological disorders, or use of antipsychotics, antidepressants, benzodiazepines, or other sedative-hypnotic drugs within 4 weeks before surgery;
2. Cognitive impairment identified by Mini-Cog screening;
3. Poorly controlled or untreated hypertension, sinus bradycardia, or severe cardiac conduction block;
4. Acute angle-closure glaucoma;
5. Known allergy to any required anesthetic drug;
6. Difficulty in electrode placement or any condition that may interfere with EEG monitoring.

Where it's running

• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting
• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Li
• Email: lizhao2001@aliyun.com
• Phone: +86-15811578082

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.